Director Clinical Operations

TRICARDIA; Maple Grove (MN); On-site; USD 180,000 - 230,000; Full time

Job summary

TRICARDIA in Maple Grove, MN, is seeking a Director of Clinical Operations to lead the pivotal FDA IDE trial for a transcatheter mitral valve therapy. The role is hands-on, requiring close collaboration with Clinical Affairs, Regulatory, Quality and investigators to keep the trial on schedule.

The ideal candidate will have 10+ years in Clinical Operations for medical devices, direct IDE trial experience, and a leadership background in fast-paced startup environments, with strong knowledge of FDA

Qualifications

• 10+ years of Clinical Operations experience within the medical device industry.
• Direct experience supporting FDA IDE pivotal clinical trials.
• Structural Heart experience is essential.
• Previous leadership experience managing Clinical Operations teams.
• Strong knowledge of FDA regulations, ICH-GCP and ISO 14155.

Responsibilities

• Lead the day-to-day execution of the pivotal clinical trial.
• Ensure investigator sites remain compliant and patients are enrolled and followed.
• Collaborate cross-functionally with Clinical Affairs, Medical Affairs, Regulatory, Quality and Data Management to deliver IDE programme.
• Drive trial performance and address operational challenges in a fast-paced environment.

Skills

Clinical Operations

FDA IDE trials

Leadership

Cross-functional collaboration

Structural Heart

Job description

Director of Clinical Operations – Structural Heart

Location: Maple Grove, MN (onsite)

Tricardia is working with a structural heart medical device company to hire an experienced Director of Clinical Operations to lead the operational execution of its FDA IDE pivotal trial for a novel transcatheter mitral valve therapy.

This is a unique opportunity to join a growing, venture-backed organisation at a critical stage of development, working alongside an experienced leadership team to help bring a transformative therapy to patients.

The Role

As Director of Clinical Operations, you'll lead the day-to-day execution of the pivotal clinical trial, ensuring investigator sites remain compliant, patients are successfully enrolled and followed, and the study progresses on schedule. You'll work cross-functionally with Clinical Affairs, Medical Affairs, Regulatory, Quality, Data Management and physician investigators to deliver a successful FDA IDE programme.

This is a hands-on leadership role suited to someone who enjoys solving operational challenges, building strong site relationships and driving clinical trial performance.

An ideal candidate will have:

• 10+ years of Clinical Operations experience within the medical device industry
• Direct experience supporting FDA IDE pivotal clinical trials
• Structural Heart experience is essential
• Previous leadership experience managing Clinical Operations teams
• Strong knowledge of FDA regulations, ICH-GCP and ISO 14155
• Experience partnering with investigators, CROs and cross-functional teams
• A proactive, collaborative approach with the ability to thrive in a fast-paced start-up environment

Why Join?

• Lead the execution of a pivotal FDA IDE trial for an innovative transcatheter mitral valve therapy
• Join a well-funded, growing structural heart company at a key stage of clinical development
• Work alongside an experienced executive leadership team with significant influence over the success of the programme
• Play a central role in bringing a breakthrough therapy closer to commercialisation